Transcription of TAGRISSO PRESCRIBING INFORMATION
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TAGRISSO PRESCRIBING INFORMATION
US-23584 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese highlights do not include all the INFORMATION needed to use TAGRISSO safely and effectively. See full PRESCRIBING INFORMATION for (osimertinib) tablets, for oral useInitial Approval: 2015--------------------------------- RECENT MAJOR CHANGES --------------------------------Indicati ons and Usage ( ) 4/2018 Dosage and Administration ( ) 4/2018 Warnings and Precautions ( , ) 4/2018--------------------------------- INDICATIONS AND USAGE ---------------------------------TAGRISS O is a kinase inhibitor indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy [see Dosage and Administration (2.1)]. 2 DOSAGE AND ADMINISTRATION. 2.1 Patient Selection. Select patients with resectable tumors for the adjuvant treatment of NSCLC with
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